|
Catalog Number UNKNOWN |
Device Problem
Patient Device Interaction Problem (4001)
|
Patient Problems
Skin Discoloration (2074); Pressure Sores (2326); Blister (4537); Skin Inflammation/ Irritation (4545); Unspecified Tissue Injury (4559)
|
Event Date 03/09/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
|
|
Event Description
|
It was reported that the patient had some blisters under breasts due to the use of arctic gel pads.Per follow-up information received from ibc on 30mar2022, stated that on (b)(6) 2021, the underside of both breasts had been excoriated and red, clotrimazole had been applied.The area's under the breasts had also been broken down further but currently there was granulation here and they would consider the area's to be grade 2 pd.Dressings had been applied.On (b)(6) 2022, patient was receiving active cooling treatment (arctic sun).The equipment the patient was wearing caused injury below their right breast.Equipment position altered.Gauze placed across area to minimize effects of pressure.Nurse in charge was informed and incident was investigated.Although noted that the arctic sun pads had caused a blister, it was noted that in the days running up to the incident it had been reported in the patient's nursing notes that they had severe moisture lesions and sore, friable skin under the breasts already.The patient had an ulcer under their breast that was though to be possibly due to the pads for the arctic sun machine being used to cool the patient.Reading the notes, the user stated that it was clear that the patient was already suffering from broken/ sore skin in this area in the days leading up to the incident.It was unlikely that the equipment alone caused the damage to the patient's skin.
|
|
Manufacturer Narrative
|
Upon further review, bd has determined that this mdr was reported in error as it was found to be a duplicate of an event previously reported.H11: section a through f - the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
|
|
Event Description
|
It was reported that the patient had some blisters under breasts due to the use of arctic gel pads.Per follow-up information received from ibc on 30mar2022, stated that on 17dec2021, the underside of both breasts had been excoriated and red, clotrimazole had been applied.The area's under the breasts had also been broken down further but currently there was granulation here and they would consider the area's to be grade 2 pd.Dressings had been applied.On 05jan2022, patient was receiving active cooling treatment (arctic sun).The equipment the patient was wearing caused injury below their right breast.Equipment position altered.Gauze placed across area to minimize effects of pressure.Nurse in charge was informed and incident was investigated.Although noted that the arctic sun pads had caused a blister, it was noted that in the days running up to the incident it had been reported in the patient's nursing notes that they had severe moisture lesions and sore, friable skin under the breasts already.The patient had an ulcer under their breast that was though to be possibly due to the pads for the arctic sun machine being used to cool the patient.Reading the notes, the user stated that it was clear that the patient was already suffering from broken/ sore skin in this area in the days leading up to the incident.It was unlikely that the equipment alone caused the damage to the patient's skin.
|
|
Search Alerts/Recalls
|
|
|